A Phase 1 Study of ABI-009 (NAB-RAPAMYCIN) in Pediatric Patients With Recurrent or Refractory Solid Tumors Including CNS Tumors as a Single Agent and in Combination With Temozolomide and Irinotecan
Investigating the Safety and Dosage of an Investigational Medication with Chemotherapy in Pediatric Solid Tumors
Brief description of study.
Detailed description of study
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: central nervous system neoplasm
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Age: 1 years - 21 years
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Gender: All
Inclusion Criteria
Patients with recurrent or refractory solid tumors, including CNS tumors, are eligible
Patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)
Patients must have either measurable or evaluable disease
Patient's current disease state must be one for which there is no known curative therapy
Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the minimum duration from prior anti-cancer directed therapy prior to enrollment
Exclusion Criteria
Pregnant or breast-feeding women will not be entered on this study
Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method both during and for 6 months after participation in this study; abstinence is an acceptable method of contraception
Patients receiving corticosteroids must have been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid
Patients who are currently receiving another investigational drug are not eligible
Patients who are currently receiving other anti-cancer agents are not eligible
Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial
Patients must not have received enzyme-inducing anticonvulsants for at least 7 days prior to enrollment
Patients who are currently receiving therapeutic anticoagulants (including aspirin, low molecular weight heparin, and others) are not eligible
Patients must not be receiving any strong CYP3A4 or P-glycoprotein (P-gp) inducers or inhibitors within 7 days prior to enrollment; moderate inducers or inhibitors of CYP3A4 and P-gp should also be avoided during ABI-009 treatment, if possible
Patients with interstitial lung disease and/or pneumonitis are not eligible
Patients with a history of allergic reactions attributed to compounds of similar composition, including macrolide and ketolide antibiotics, temsirolimus/other mTOR inhibitors, temozolomide or irinotecan are not eligible
Patients with hypersensitivity to albumin are not eligible
Patients with current deep vein thrombosis or deep vein thrombosis within the past 6 months are not eligible
Patients who have an uncontrolled infection are not eligible
Patients who have received a prior solid organ transplantation are not eligible
Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible
This study investigates the safety and best dose of an investigational medication given with chemotherapy drugs, temozolomide and irinotecan, in children with solid tumors that have returned or not responded to treatment. Solid tumors are growths of abnormal cells that can occur in various parts of the body. This study focuses on finding the right dose of the investigational medication, which is given through an IV, and understanding its effects on the body.
Participants will receive the investigational medication through an intravenous infusion over 30 minutes on specific days of a 21-day cycle, along with the chemotherapy drugs. The study will monitor any side effects and how the body absorbs the medication. This process helps researchers learn more about the investigational medication's safety and how it works when combined with other treatments.
- Who can participate: Children with solid tumors that have come back or not responded to treatment can participate. They must have a confirmed diagnosis and either measurable or evaluable disease. Participants should not be pregnant, breastfeeding, or on certain medications. They must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and meet the minimum duration from prior therapy.
- Study details: Participants will receive an investigational medication through an IV, along with chemotherapy drugs, on specific days of a cycle. A placebo will not be used in this study. Participants will not be paid for their participation.
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